PPT-IRB RESEARCH REPOSITORY

COMPLIANCE PROGRAM Repository Protocols and FAQs Compliance Deadline August 31 2011 Kathryn Schuff MD MCR Andrea Johnson JD IRB CoChair Regulatory Specialist ORIO Agenda Whats a repository. Micheal A. Kuhn, MD. Vice Chair, Loma Linda University. Institutional Review Board. What type of . research needs. IRB review?. Anything and everything . that involves human subjects. Navigating the IRB process. A How-To Guide. http://www.uthsc.edu/research/research_compliance/IRB. /. (901) 448-4824. irb@uthsc.edu. UTHSC Institutional Review . Board (IRB). Charged with protecting human research subjects. Ensures compliance with the federal regulations (DHHS, FDA, & HIPAA) with regards to research applications, consent forms and other research materials to be used; and with regards to the conduct of the research itself. :. H. ow collaboration contributed to the development of a CRIS (Pure). Kate Croker. Associate Manager (Research Publications & Data Services). UWA . RA/4/1/8418. Outline of presentation . UWA context. Objectives. Define research and human subjects research.. Show the "gray area" between research and practice.. Describe the distinction between a medical education initiative and a medical education research initiative.. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality Assurance. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. From Initial Submission, Through the Informed Consent Process and Continuing Review, To Inactivation. Kimberly Summers, PharmD. Deputy ACOS for Research. South Texas Veterans Health Care System. Research & Development Service. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality . Assurance. Updated: . 03/13/2017. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. A Brief Overview of the Types of Projects Which Need IRB Oversight. Back to Basics…. Anyone engaged in human subjects research at Emory is bound to comply with regulations and policies for protecting participants. . Hila Berger, Director Research Integrity and Compliance. Mylka Biascochea, Compliance Coordinator IRB/IACUC. 1. Objectives . What is the Institutional Review Board (IRB) responsible for? And why?. What is Human subjects research?. Amy Krenzer, CIP, IRB Coordinator. Hila Berger, MPH, CIP, Research compliance Officer. 1. Objectives . What is the Institutional Review Board (IRB) responsible for? And why?. What is Human subjects research?. Obtaining . protocol approval . Melanie Locher, B.S., CIP. Assistant Director of Monitoring and Education, . UVM Research Protections Office. Aims of today’s presentation. Detail the steps for a PI to obtain IRB approval. Institutional Review Board. What is an IRB?. What is its job?. What are its guiding Principles?. Belmont Report (i.e., Respect for Persons, Beneficence, Justice). Code of Federal Regulations, Title 45 – Public Welfare, Part 46 Protection of Human Participants (aka . Let’s Play Jeopardy!. Go to the Bank. Time for Your Review. Fast Lane. I’ve Got Friends. 200. 200. 200. 200. 400. 400. 400. 400. 600. 600. 600. 600. Go to the Bank for 200. You have a population of interest (e.g., women who have been diagnosed with breast cancer) that you would like to contact for future studies.. What Every Investigator. (and his/her research staff). Should Know about. Conducting. Human Research Activities. *. Based on David Lettermen’s Top Ten . PI Responsibility #1. In designing the study, the investigator should take into consideration the three underlying ethical principles for conducting research with human subjects as delineated in the.